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Heart Imaging in Children With Muscular Dystrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01633242
Recruitment Status : Terminated
First Posted : July 4, 2012
Last Update Posted : September 13, 2019
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Brief Summary:


- Muscular dystrophy can affect the muscles used for heart function and breathing. Treatment usually involves drugs that help improve heart function. However, better types of heart imaging studies are needed to improve treatment of heart problems related to muscular dystrophy. Better heart imaging methods are especially needed for children with muscular dystrophy. Researchers want to test different heart imaging methods in children with muscular dystrophy. They will look at cardiac magnetic resonance imaging (MRI) and standard heart function tests.


- To develop and test new methods for imaging the heart in children with muscular dystrophy.


- Children and adolescents between 8 and 17 years of age who have muscular dystrophy.


  • Participants will be screened with a physical exam and medical history.
  • Participants will provide a blood sample at the start of the study. They will also have heart function tests before having the imaging study.
  • Participants will have a cardiac MRI scan that will last up to 60 minutes. Some tests will require a MRI contrast agent (a drug that helps the image appear more clearly on the scan).

Condition or disease
Muscular Dystrophy

Detailed Description:
Cardiomyopathy causes significant morbidity and mortality in multiple forms of muscular dystrophy affecting children, including Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD) and subtypes of autosomal recessive limb-girdle muscular dystrophy (LGMD2). Pharmaceutical treatments for the cardiomyopathy of muscular dystrophy, including angiotensin-converting enzyme (ACE) inhibition and beta-adrenergic receptor blockade, afford significant benefit and demonstrate cardiac remodeling in clinical studies. Further studies are needed to identify and characterize more sensitive indicators of cardiac dysfunction in muscular dystrophy subjects to better stratify subjects for entry into clinical protocols. Using the framework of the Cooperative International Neuromuscular Research Group (CINRG) and the Clinical and Translational Science Award (CTSA) consortium, this pilot study will assess cardiac outcome measures in children obtained by gadolinium enhanced cardiac Magnetic Resonance Imaging (MRI) and echocardiographic methods that can be reliably implemented across a consortium of clinical sites devoted to the study of pharmaceutical treatments for muscular dystrophy. These cardiac MRI scans will be shared with the PITT1109 research protocol in all subjects that are enrolled in both studies.

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Study Type : Observational
Actual Enrollment : 2 participants
Time Perspective: Prospective
Official Title: A Pilot Study of Cardiac Magnetic Resonance in Patients With Muscular Dystrophy
Study Start Date : February 24, 2012
Study Completion Date : October 11, 2016

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Evaluate CMR measures in muscular dystrophy patients

Secondary Outcome Measures :
  1. Early Detection
  2. Measurement of Disease Progression
  3. Ultimate identification of the response to developing therapies

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Male or females with a diagnosis of Duchenne, Becker, or Limb Girdle Muscular Dystrophy.
  • 8 to 100 years of age.


  • Day-time users of continuous positive airway pressure (CPAP)
  • Sip ventilator users
  • Invasive ventilator dependent
  • Pregnant minors (when uncertain, participants will undergo urine testing) or lactating minors
  • Decompensated congestive heart failure (unable to lie flat during CMR)
  • Impaired renal excretory function (calculated Glomerular Filtration Rate less than 30mL/min)
  • Contra-indications to Magnetic Resonance Imaging:

    • Cardiac pacemaker or implantable defibrillator
    • Cerebral aneurysm clip
    • Neural stimulator
    • Metallic ocular foreign body
    • Harrington-rod
    • Any implanted device (i.e. insulin pump, drug infusion device)
    • Claustrophobia
    • Metal shrapnel or bullet
  • Investigator assessment of inability to comply with protocol
  • Unable/unwilling to lie still throughout the research procedure or who require sedation
  • Persons with cognitive impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01633242

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Andrew E Arai, M.D. National Heart, Lung, and Blood Institute (NHLBI)
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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI) Identifier: NCT01633242    
Other Study ID Numbers: 120090
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: October 11, 2016
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Muscular Dystrophy
Intramyocardial fat
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn